U

UCSF

Public health sciences university in San Francisco

Clinical Research Coordinator

Medical ResearchConfirmed live in the last 24 hours
Full-timeSan Francisco, CA, USA$40.14 - $47.05

About the Job

Requirements

  • High school graduation and experience in clinical research coordination, clinical research operations, or a related research environment involving human subjects.
  • Knowledge of clinical research regulations and guidelines, including Good Clinical Practice, Human Subjects Protection regulations, the Health Insurance Portability and Accountability Act, and Institutional Review Board processes and compliance requirements.
  • Experience coordinating clinical research studies, including participant recruitment, informed consent procedures, study visit coordination, and protocol implementation.
  • Experience collecting, documenting, and managing research data, including completing and maintaining case report forms and maintaining accurate study records.
  • Ability to accurately execute clinical research protocols in a timely manner.
  • Ability to coordinate multiple concurrent clinical research studies and manage competing priorities while maintaining protocol compliance.
  • Experience working directly with research participants or patients, including scheduling visits, coordinating procedures, and maintaining professional communication.
  • Experience collecting, processing, and coordinating the shipment of biological specimens in accordance with study protocols and safety regulations.
  • Strong organizational, analytical, and problem-solving skills, with demonstrated ability to manage detailed documentation and maintain data integrity.
  • Proficiency with Microsoft Office software, including Word and Excel.
  • Interest and ability to work with participants in a clinical research setting.
  • Ability to work onsite depending on project needs.
  • Proficiency with standard computer applications and research documentation tools, including electronic medical records and database systems.

Responsibilities

  • Execute, manage, and coordinate research protocols independently or with general direction, as directed by the Clinical Research Supervisor or Principal Investigator.
  • Coordinate clinical research studies and clinical care for patients with Parkinson’s disease and other movement disorders, including drug treatments and observational studies.
  • Interact frequently with patients; coordinate and attend complex clinic and study visits; collect research data; manage databases, case report forms, supplies, and regulatory documents; and collect, process, and ship biological specimens.
  • Support management and coordinate tasks for single or multiple clinical research studies, depending on their size and complexity.
  • Act as an intermediary between services and departments while overseeing data and specimen management.
  • Manage and report study results; create, clean, update, and manage databases, comprehensive datasets, and reports.
  • Coordinate staff work schedules, assist with training Assistant CRCs, and assist the Clinical Research Supervisor or Principal Investigator with oversight of other research staff.
  • Manage investigator protocols in the Committee on Human Research online system, including renewals and modifications of protocol applications and implementation of new studies.
  • Participate in reviewing and writing protocols to ensure institutional review board approval and university compliance.
  • Help assure compliance with relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures.
  • Interface with departments to obtain university approval before study initiation; maintain regulatory documents; report study progress to investigators; and participate in internal and external audits or reviews of study protocols.
  • Identify subjects; develop recruitment and retention strategies; and screen and enroll study subjects.
  • Schedule study visits; administer questionnaires; collect medical histories; and perform study procedures.
  • Maintain relationships with subjects, support communication and retention, respond to diverse needs, schedule follow-up appointments, act as an intermediary for participants, and discuss study outcomes with providers to ensure continuity of care.
  • Obtain informed consent, review information with subjects, and assess and advocate for patient safety throughout protocol procedures.
  • Oversee subject reimbursement and resolve discrepancies and issues.
  • Work with staff to ensure procedures are completed, specimens are properly stored, required visit data are collected, and shipments and labeling are correct.
  • Coordinate with other studies, technicians, and affiliated groups to improve scheduling efficiency.
  • Review medical charts and electronic records to extract information for studies.
  • Assess needs and recommend enhancements to patient coordination, data collection, data management, protocol adherence, and study collaboration.
  • Collect and enter data from visits, procedures, laboratory tests, and other subject participation into databases in a timely manner.
  • Manage database structure for each protocol, update databases to improve data analysis and management, and create new databases as needed.
  • Create and maintain comprehensive datasets; maintain data collection forms; perform database queries and analysis; and work with the supervisor to maintain accurate study databases and analyze available data.
  • Train staff and others on new protocols, procedure changes, study protocols, data collection and entry, database procedures, medical chart review and storage, and other procedures.
  • Attend and actively participate in regular team meetings.
  • Oversee data integrity and assess the adequacy of policies and procedures for subject recruitment, data collection, and data management.
  • Update and maintain procedure manuals and help develop plans to ensure consistency in data collection and entry.
  • Suggest modifications to administrative infrastructure to accommodate increasing study complexity; modify data collection instruments; and help schedule staff time and coordinate staff schedules.
  • Maintain subject tracking systems; arrange specimen exchange and transport with collaborating investigators and staff; oversee incoming data interpreted from samples and ensure appropriate use for analysis and publications; and ensure sample integrity and security.
  • Enter existing and new study protocols into the Committee on Human Research online system; maintain protocols by communicating with Committee on Human Research analysts.
  • Design and enhance case report forms and data collection forms; provide manuscript feedback; and develop and maintain systems for protocol adherence and data quality.
  • Renew, modify, and submit Committee on Human Research applications and protocols; ensure timely protocol submissions; and serve as liaison between the Committee on Human Research and study investigators.
  • Perform ongoing quality assurance checks and protocol evaluations, identify when protocols or applications need modification, and implement improvements.
  • Carry out studies according to the Code of Federal Regulations, Good Clinical Practice, and university regulations.
  • Initiate and follow up on Committee on Human Research submissions and modifications, and track approval status.
  • Maintain regulatory documents, monitor data-submission timelines, document adverse events, and submit them to appropriate departments.
  • Maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
  • Participate in and cooperate with internal and external audits or reviews of study protocols, and prepare necessary documentation.

About the Company

UCSF

Public health sciences university in San Francisco

UC San Francisco is a public research university in San Francisco focused solely on health sciences, combining professional education with biomedical research and patient care. Its schools of dentistry, medicine, nursing and pharmacy train clinicians and scientists, while teams investigate cancer, immunology, genomics and neuroscience. UCSF Medical Center and Benioff Children's Hospitals connect clinical care with faculty research and training, and university clinics serve patients across Northern California. Founded in 1864, UCSF is the University of California campus dedicated to graduate and professional education and biomedical research, based in San Francisco.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Not listed
Founded
1864

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